MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION SWIFT LOCK ANCHOR; SCS ANCHOR

Model Number 1192

Device Problems Kinked (1339); Device Operates Differently Than Expected (2913)

Patient Problem Inadequate Pain Relief (2388)

Event Date 02/03/2014

Event Type  Injury  

Event Description

Device 2 of 2.Ref mfr.Report #: 1627487-2014-21125.The pt received two scs leads and two scs anchors, each have the same lot number.It was reported the pt was not receiving right-sided stimulation.Diagnostics revealed multiple invalid impedances.X-rays did not provide certainty if the lead had migrated, however; there were multiple loops/ kinks observed at the anchor site.Follow-up identified surgical intervention will be taken to address the issue.

Manufacturer Narrative

Sjm has limited information related to the patient's medical history and is unable to form an opinion as to the relevancy of the patient's history to the event reported.Sjm defers to the patient's physician regarding medical history.

• Brand Name: SWIFT LOCK ANCHOR
• Type of Device: SCS ANCHOR
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; plano TX
• Manufacturer Contact: palka sharma ; 6901 preston rd.; plano, TX 75024 ; 9725264823
• MDR Report Key: 3697141
• MDR Text Key: 4263954
• Report Number: 1627487-2014-21126
• Device Sequence Number: 1
• Product Code: GZB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K092371
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 02/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2014
• Device Model Number: 1192
• Device Lot Number: 3639525
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/03/2014
• Initial Date FDA Received: 02/25/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: IMPLANT DATE:; SCS IPG, MODEL 3716
• Patient Outcome(s): Other
• Patient Age: 41 YR